Incorporating Endoscopic Ultrasound and Elastography Towards Improving Outcomes of Pediatric Pancreatitis Management

Not Applicable

Completed

Conditions: Chronic Pancreatitis
Acute Recurrent Pancreatitis

Registration Number: NCT06068426

Lead Sponsor: David Vitale MD

Brief Summary: The main reason for this research study is to find out more about acute recurrent pancreatitis and chronic pancreatitis in children. There are few studies on childhood pancreatitis, so diagnosis and treatment are based on adult studies. This limits our understanding and treatment of these disorders in children.

Endoscopic ultrasound (EUS) is a tool used to assess and diagnose pancreatic disease. We can use ultrasound with shear wave elastography (SWE) to measure fibrosis (scarring) of the pancreas. We can use SWE on both EUS and transabdominal ultrasound (TUS) systems. Both TUS and EUS SWE have been studied for diagnosis of chronic pancreatitis in adult patients, however they have not been studied in children.

We plan to use EUS SWE and TUS SWE information in this study to help us understand pancreatitis in children. Children with pancreatitis and children without pancreatitis (controls) will be invited to participate in this study.

Detailed Description: The aims of the proposed study are as follows:

Aim 1: Characterize endoscopic ultrasound (EUS) findings of pediatric acute recurrent pancreatitis (ARP) and chronic pancreatitis (CP).

Adult criteria for EUS diagnosis of CP exist, but no such criteria exist for children. As such, the applicability of current diagnostic criteria to pediatric patients is unknown.

1.1: Catalogue grayscale EUS findings of ARP and CP in a pediatric cohort and compare to healthy controls. Hypothesis: EUS findings of ARP and CP in pediatric patients will differ from those of adult ARP and CP and will be characteristically different from healthy controls. Exp1: We will catalogue grayscale EUS findings in 40 pediatric

patients with known history of ARP or CP undergoing clinically indicated EUS and will compare those with findings in 20 patients without a history of pancreatitis who are undergoing EUS for other indications.

1.2: Benchmark grayscale EUS against other imaging modalities for diagnosis of CP, particularly early CP, in children. Hypothesis: Grayscale EUS findings will be more sensitive than other imaging modalities in all stages of CP. Exp2: We will test associations, in blinded fashion, of grayscale EUS findings catalogued under S.A1.1 in enrolled children with findings on alternative pancreas imaging modalities performed for clinical indications. Specifically, we will correlate to endoscopic retrograde cholangiopancreatography (ERCP), magnetic resonance cholangiopancreatography (MRCP) and computed tomography (CT) performed for clinical indications within +/- 3 months of the EUS.

Aim 2: Define the diagnostic performance of ultrasound elastography for CP and pancreatic stiffness as a measure of fibrosis in pediatric patients.

2.1: Define the diagnostic performance of EUS and TUS elastography for pediatric CP. Hypothesis: EUS and TUS elastography will have high specificity for CP with increased stiffness in patients compared to controls. Exp 1: Patients enrolled under Aim 1 will undergo shear wave elastography (SWE) measurement of the pancreas during EUS. These same patients will undergo research TUS with SWE of the pancreas. SWE results by both EUS and TUS will be evaluated for diagnostic performance for CP.

2.2: Define agreement between EUS and TUS measurement of pancreatic parenchymal stiffness in pediatric patients. Hypothesis: EUS and TUS measures of pancreatic parenchymal stiffness will agree with minimal bias. Exp2: EUS and TUS SWE data obtained under S.A2.1 will be evaluated for agreement and divergent cases will be investigated to define causes.

2.3: Define the diagnostic performance of elastography for pancreatic fibrosis. Hypothesis: SWE is a sensitive indicator of pancreatic fibrosis as identified by histology. Exp3: Patients undergoing clinically indicated total pancreatectomy and islet auto transplant (TPIAT) or other pancreatic surgical resection at our institution (approximately 20 per year) will be approached to undergo pre-operative TUS SWE. These SWE measurements, along with EUS SWE measurements obtained preoperatively, will be compared to binary and semi-quantitative assessments of pancreatic parenchymal fibrosis by histology.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 66

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
EUS Pancreatic Findings- Rosemont Criteria	At time of EUS procedure	Rosemont Criteria Features * Hyperechoic foci with shadowing (Major A) * Lobularity with honeycombing (Major B) * Lobularity without honeycombing (Minor) * Hyperechoic foci without shadowing (Minor) * Cysts (Minor) * Stranding (Minor) * Main pancreatic duct calculi (Major A) * Irregular main pancreatic duct contour (Minor) * Dilated side branches (Minor) * Main pancreatic duct dilation (Minor) * Hyperechoic main pancreatic duct margin (Minor)

Secondary Outcome Measures

Name	Time	Method
Acute Recurrent Pancreatitis	6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)	The presence or absence of recurrence of pancreatitis.
Diabetes Mellitus	6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)	The presence or absence of a diagnosis of diabetes.
Calculated BMI	6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)	Capturing weight(kg) and height(cm) to calculate
Chronic Pancreatitis	6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)	The presence or absence of Chronic pancreatitis diagnosis
Exocrine Pancreatic Insufficiency	6 months (3 months prior to endoscopic ultrasound through 3 months post-endoscopic ultrasound)	The presence or absence of exocrine pancreatic insufficiency diagnosis.
MRI Cambridge Grade: Mild	At time of MRI	Cambridge Grade: 1. (Normal) 2. (Equivocal) 3. (Mild) 4. (Moderate) 5. (Severe)
ERCP Cambridge Criteria: Mild	At time of ERCP	Cambridge Criteria 1. (Normal) 2. (Equivocal) 3. (Mild) 4. (Moderate) 5. (Marked)
EUS Rosemont Classification - Normal	At time of EUS	The Rosemont classification has been established to standardize an approach to EUS diagnosis of CP. The following criteria are used to determine the classification. Hyperechoic foci with shadowing Lobularity with honeycombing Lobularity without honeycombing Hyperechoic foci without shadowing Cysts Stranding Main pancreatic duct calculi Irregular main pancreatic duct contour Dilated side branches Main pancreatic duct dilation Hyperechoic main pancreatic duct margin
EUS Rosemont Classification - Suggestive of CP	At time of EUS	The Rosemont classification has been established to standardize an approach to EUS diagnosis of CP. The following criteria are used to determine the classification. Hyperechoic foci with shadowing Lobularity with honeycombing Lobularity without honeycombing Hyperechoic foci without shadowing Cysts Stranding Main pancreatic duct calculi Irregular main pancreatic duct contour Dilated side branches Main pancreatic duct dilation Hyperechoic main pancreatic duct margin
EUS Rosemont Classification - Indeterminate for CP	At time of EUS	The Rosemont classification has been established to standardize an approach to EUS diagnosis of CP. The following criteria are used to determine the classification. Hyperechoic foci with shadowing Lobularity with honeycombing Lobularity without honeycombing Hyperechoic foci without shadowing Cysts Stranding Main pancreatic duct calculi Irregular main pancreatic duct contour Dilated side branches Main pancreatic duct dilation Hyperechoic main pancreatic duct margin
MRI Cambridge Grade: Normal	At time of MRI	Cambridge Grade: 1. (Normal) 2. (Equivocal) 3. (Mild) 4. (Moderate) 5. (Severe)
EUS Rosemont Classification - Consistent With CP	At time of EUS	The Rosemont classification has been established to standardize an approach to EUS diagnosis of CP. The following criteria are used to determine the classification. Hyperechoic foci with shadowing Lobularity with honeycombing Lobularity without honeycombing Hyperechoic foci without shadowing Cysts Stranding Main pancreatic duct calculi Irregular main pancreatic duct contour Dilated side branches Main pancreatic duct dilation Hyperechoic main pancreatic duct margin
ERCP Cambridge Criteria: Equivocal	At time of ERCP	Cambridge Criteria 1. (Normal) 2. (Equivocal) 3. (Mild) 4. (Moderate) 5. (Marked)
MRI Cambridge Grade: Equivocal	At time of MRI	Cambridge Grade: 1. (Normal) 2. (Equivocal) 3. (Mild) 4. (Moderate) 5. (Severe)
MRI Cambridge Grade: Moderate	At time of MRI	Cambridge Grade: 1. (Normal) 2. (Equivocal) 3. (Mild) 4. (Moderate) 5. (Severe)
MRI Cambridge Grade: Severe	At time of MRI	Cambridge Grade: 1. (Normal) 2. (Equivocal) 3. (Mild) 4. (Moderate) 5. (Marked)
ERCP Cambridge Criteria: Normal	At time of ERCP	Cambridge Criteria 1. (Normal) 2. (Equivocal) 3. (Mild) 4. (Moderate) 5. (Marked)
ERCP Cambridge Criteria: Moderate	At time of ERCP	Cambridge Criteria 1. (Normal) 2. (Equivocal) 3. (Mild) 4. (Moderate) 5. (Marked)
ERCP Cambridge Criteria: Marked	At time of ERCP	Cambridge Criteria 1. (Normal) 2. (Equivocal) 3. (Mild) 4. (Moderate) 5. (Marked)

Trial Locations

Locations (1): Cincinnati Children's Hospital Medical Center
🇺🇸
Cincinnati, Ohio, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States